Stent retrieval member and devices and methods for retrieving or repositioning a stent

ABSTRACT

An implantable stent includes a stent retrieval member for repositioning or retrieval of the stent after it has been implanted into a bodily lumen. The stent includes a distensible tubular stent having a tubular structure having a tubular wall defined by an interior surface and an exterior surface and having opposed open ends; and a stent retrieval member comprising an elongate member comprising a generally circular perimetric base and a shaped projection having first and second spaced apart members extending acutely or perpendicularly from the base and connected by an apical portion. Force exerted on the shaped projection causes contraction or expansion of the circular base. The circular base is securably attached to one of the open ends of the stent, and the shaped projection extends longitudinally beyond this open end of the stent.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.60/647,981, filed Jan. 28, 2005, the contents of which are incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention relates to devices, methods and systems forretrieval and/or repositioning of an implanted stent. More particularly,the present invention relates to implantable stents having a stentretrieval member or loop for easy for retrieval and/or repositioning ofthe implanted stent.

BACKGROUND OF THE INVENTION

An intraluminal prosthesis is a medical device used in the treatment ofdiseased bodily lumens. One type of intraluminal prosthesis used in therepair and/or treatment of diseases in various body vessels is a stent.A stent is a generally longitudinal tubular device formed ofbiocompatible material which is useful to open and support variouslumens in the body. For example, stents may be used in the vascularsystem, urogenital tract, esophageal tract, tracheal/bronchial tubes andbile duct, as well as in a variety of other applications in the body.These devices are implanted within the vessel to open and/or reinforcecollapsing or partially occluded sections of the lumen.

Stents generally include an open flexible configuration. Thisconfiguration allows the stent to be inserted through curved vessels.Furthermore, this configuration allows the stent to be configured in aradially compressed state for intraluminal catheter implantation. Onceproperly positioned adjacent the damaged vessel, the stent is radiallyexpanded so as to support and reinforce the vessel. Radial expansion ofthe stent may be accomplished by inflation of a balloon attached to thecatheter or the stent may be of the self-expanding variety which willradially expand once deployed. Structures which have been used asintraluminal vascular grafts have included coiled stainless steelsprings; helically wound coil springs manufactured from a heat-sensitivematerial; and expanding stainless steel stents formed of stainless steelwire in a zig-zag pattern.

Various techniques or systems have been proposed for retrieving and/orrepositioning an implanted stent. For example, U.S. Pat. No. 5,643,277to Soehendra et al. describes the use of a tapered, threaded cable forremoval of an implanted stent. The threaded portion of the cable isdescribed as being twisted to engage an implanted biliary stent, such asa polyethylene stent, and then pulled to remove the sent from thepatient.

U.S. Pat. No. 6,676,692 to Rabkin et al. describes a catheter systemhaving stent-capturing hooks. The hooks are described as being usefulfor engaging the stent, thereby allowing repositioning and/or retrievalof the stent.

U.S. Patent Application Publication No. 2002/0188344 A1 to Bolea et al.describes the use of hinged hooks attached to interior portions of animplantable stent. Use of a retrieval tool is described as engaging thehooks, and, upon twisting of the retrieval tool, the stent is contractedthereby allowing retrieval of the stent. In another embodiment, a wirelasso is described as being secured to an implantable stent with thewire lasso having a small loop internally disposed within the open lumenof the stent. The loop of the lasso is described as being engaged by aretrieval tool, and, upon twisting of the retrieval tool, the stent iscontracted thereby allowing retrieval of the stent. Other embodimentsinclude a lasso wire threaded through eyelets at a stent end. Aretrieval tool is described as engaging the lasso wire, and, upontwisting or axially pulling the lasso wire, the stent is contractedthereby allowing retrieval of the stent.

Prior retrieval systems may appear easy to use, but often requirecertain user-sensitive techniques, such as twisting or turning in orderto reposition or remove the stent. Moreover, in smaller stents, such asbiliary stents, the spacing between conventional stent segments isgenerally smaller than the size of standard forceps or graspers, makingit even difficult to grab a hook or lasso.

SUMMARY OF THE INVENTION

The present invention provides a stent retrieval system that allows foreasy access to the retrieval member located on an implantable stent.Further, the stent removal member of the present invention avoidscomplicated twisting movements for retrieval or repositioning of theimplanted stent.

In one aspect of the present invention, an implantable distensible bandis provided. The band comprises an elongate member comprising agenerally circular perimetric base implantable within a bodily lumen anda shaped projection having first and second spaced apart membersextending acutely or perpendicularly from the base and connected by anapical portion, whereby force exerted on the shaped projection causescontraction or expansion of the circular base. The elongate member maybe a strand, such as a wire strand, either a monofilament ormultifilament strand. Desirably, such bands may function as retrievalmembers when used in conjunction with a stent or a graft.

In another aspect of the present invention, an implantable stent isprovided. The stent comprises: (i) a distensible tubular stent having atubular structure having a tubular wall defined by an interior surfaceand an exterior surface and having opposed open ends; and (ii) a stentretrieval member comprising an elongate member comprising a generallycircular perimetric base and a shaped projection having first and secondspaced apart members extending acutely or perpendicularly from the baseand connected by an apical portion, whereby force exerted on the shapedprojection causes contraction or expansion of the circular base, whereinthe circular base is securably attached to one of the open ends of thestent and further wherein the shaped projection extends longitudinallybeyond the one open end of the stent.

In another aspect of the present invention, a method of retrieving orrepositioning an implanted stent is provided. The method comprises thesteps of (a) providing a tubular distensible stent comprising (i) a wallto define an interior surface and an exterior surface and having opposedopen ends; and (ii) a stent retrieval member comprising an elongatemember comprising a generally circular perimetric base implantablewithin a bodily lumen and a shaped projection having first and secondspaced apart members extending acutely or perpendicularly from the baseand connected by an apical portion, whereby force exerted on the shapedprojection causes contraction or expansion of the circular base, whereinthe circular base is securably attached to one of the open ends of thestent and further wherein the shaped projection extends longitudinallybeyond the one open end of the stent; (b) implanting the stent within abodily lumen; and (c) pulling the shaped projection of the stentretrieval member to contract the first end of the stent and to move thestent.

In another aspect of the present invention, a method of retrieving orrepositioning an implanted stent is provided. The method comprises thesteps of (a) locating a distensible stent within a bodily lumen, thestent comprising a hollow tubular structure having a tubular wall todefine an interior surface and an exterior surface and having opposedopen ends and a stent retrieval member comprising an elongate membercomprising a generally circular perimetric base implantable within abodily lumen and a shaped projection having first and second spacedapart members extending acutely or perpendicularly from the base andconnected by an apical portion, whereby force exerted on the shapedprojection causes contraction or expansion of the circular base, whereinthe circular base is securably attached to one of the open ends of thestent and further wherein the shaped projection extends longitudinallybeyond the one open end of the stent; and (b) pulling the shapedprojection of the stent retrieval member to contract the first end ofthe stent and to move the stent.

In another aspect of the present invention, a system is provided. Thesystem comprises (a) a distensible stent, said stent comprises (i) ahollow tubular structure having a tubular wall to define an interiorsurface and an exterior surface and having opposed open ends; and (ii) astent retrieval member comprising an elongate member comprising agenerally circular perimetric base implantable within a bodily lumen anda shaped projection having first and second spaced apart membersextending acutely or perpendicularly from said base and connected by anapical portion, whereby force exerted on said shaped projection causescontraction or expansion of said circular base, wherein said circularbase is securably attached to one of said open ends of said stent andfurther wherein said shaped projection extends longitudinally beyondsaid one open end of said stent; and (b) a delivery catheter forimplanting said stent.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a hollow, tubular stent according to thepresent invention.

FIG. 2 is an expanded view of a wall portion of the stent of FIG. 1taken along the 2-2 axis showing a plurality of stent wires.

FIG. 3 depicts a braided stent with a closed-end loop design at bothstent ends.

FIG. 4 is a perspective view of a stent retrieval loop according to thepresent invention having a circular base and a projecting member.

FIG. 5 is a top view of the stent retrieval loop of FIG. 4 taken alongthe 5-5 axis.

FIG. 6 is a front elevational view of the stent retrieval loop of FIG. 4taken along the 6-6 axis.

FIG. 7 is a side elevational view of the stent retrieval loop of FIG. 4taken along the 7-7 axis.

FIG. 8 is an expanded view of the projecting member of FIG. 4.

FIG. 9 is an expanded view of a first alternative design for theprojecting member of FIG. 8.

FIG. 10 is an expanded view of a second alternative design for theprojecting member of FIG. 8.

FIG. 11 is an expanded view of a third alternative design for theprojecting member of FIG. 8.

FIG. 12 is an expanded view of a fourth alternative design for theprojecting member of FIG. 8.

FIG. 13 is an expanded view of a fifth alternative design for theprojecting member of FIG. 8.

FIG. 14 is a side elevational view of the stent of FIG. 3 having thestent retrieval loop of FIG. 4 at one of the ends of the stent.

FIG. 15 is a front elevational view of the stent of FIG. 3 having thestent retrieval loop of FIG. 4 at one of the ends of the stent.

FIG. 16 is a perspective view of the stent of FIG. 3 having the stentretrieval loop of FIG. 4 at one of the ends of the stent.

FIG. 16A is a perspective view of the stent of FIG. 3 having the stentretrieval loop of FIG. 4 at one of the ends of the stent and more thanone shaped projection.

FIG. 17 is a side elevational view of the stent of FIG. 14 having aninwardly projecting stent retrieval loop.

FIG. 18 is a side elevational view of the stent of FIG. 14 having aninwardly and acutely projecting stent retrieval loop.

FIG. 19 depicts a stent having a covering of silicone according to thepresent invention.

FIG. 20 is a cross-sectional view of the stent of FIG. 19 showing anouter covering of silicone about the stent.

FIG. 21 is a cross-sectional view of the stent of FIG. 19 showing aninner covering of silicone about the stent.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 depicts stent 10 of the present invention. Stent 10 is a hollowtubular structure having opposed open ends 12, 14 and having a tubularwall 16 therebetween. A portion of the tubular wall 16 is depicted inFIG. 2 as having a plurality of elongate wires 18 formed into thetubular wall 16. The elongate wires 18 traverse the length of the stent10 in a direction traverse to the longitudinal length of the stent 10.The elongate wires 18 may be formed into the tubular wall 16 by braidingthe wires 18, winding the wires 18, knitting the wires 18, andcombinations thereof. Preferably, the wires 18 are braided to form thetubular wall 16.

As depicted in FIG. 3, stent 10 is desirably an atraumatic stent havingno sharp terminating members at one or both of the opposed open ends 12,14. The elongate wires 18 terminating at open end 12 are mated to formclosed loops 13 and adjacently mated wires are secured to one and theother by mechanical means, such as welds 20. The positioning ofadjacently mated wires to form closed-loop end designs is furtherdescribed in U.S. Application No. 60/472,929, filed May 23, 2003, thecontents of which are incorporated herein by reference. Desirably, theelongate wires 18 terminating at open end 12 are in a cathedral typearch or loop configuration. Further details of the cathedral type ofarch or closed-loop configuration may be found in U.S. application Ser.No. 10/845,844, filed May 15, 2004, the contents of which areincorporated herein by reference.

The stent wires 18 at the open end 14 are bent to form closed loop ends15 thereat. As depicted in FIG. 3, the loop ends 15 are substantiallyangular having approximately or about a 90° bend. The radius ofcurvature at the point of the bend is desirably minimized. In otherwords, the loop end 15 desirably has an angularly bent portion betweensubstantially straight wire portions that do not otherwise have aportion with a significant radius of curvature. The loop ends 15,however, are not limited to angular bends of 90° and other bend anglesmay suitably be used. For example, angular bends with a bend angle fromabout 30° to about 150° are also useful. Other useful bend anglesinclude from about 60° to about 120°, from about 70° to about 10°, fromabout 80° to about 100°, from about 85° to about 95°, and the like.

The stent 10 depicted in FIG. 3 includes multiple wires, such as 24wires 18 as depicted in FIG. 3, of nitinol or nitinol-containingmaterial. The wires are relatively thin at a diameter of about 0.011inches. The number of wires and the diameters of the wires, which may bethe same or different, depicted in FIG. 3 are not limiting, and othernumbers of wires and other wire diameters may suitably be used.

Desirably, the wires 18 are made from any suitable implantable material,including without limitation nitinol, stainless steel, cobalt-basedalloy such as Elgiloy®, platinum, gold, titanium, tantalum, niobium,polymeric materials and combinations thereof. Useful and nonlimitingexamples of polymeric stent materials include poly(L-lactide) (PLLA),poly(D,L-lactide) (PLA), poly(glycolide) (PGA),poly(L-lactide-co-D,L-lactide) (PLLA/PLA), poly(L-lactide-co-glycolide)(PLLA/PGA), poly(D,L-lactide-co-glycolide) (PLA/PGA),poly(glycolide-co-trimethylene carbonate) (PGA/PTMC), polydioxanone(PDS), Polycaprolactone (PCL), polyhydroxybutyrate (PHBT),poly(phosphazene) poly(D,L-lactide-co-caprolactone) PLA/PCL),poly(glycolide-co-caprolactone) (PGA/PCL), poly(phosphate ester) and thelike.

Further, the wires 18 may have a composite construction, such asdescribed found in U.S. Patent Application Publication 2002/0035396 A1,the contents of which is incorporated herein by reference. For example,the wires 18 may have an inner core of tantalum gold, platinum, iridiumor combination of thereof and an outer member or layer of nitinol toprovide a composite wire for improved radiocapicity or visibility.Preferably, the wires 18 are made from nitinol.

Either of both of the opposed open ends 12, 14 of the stent 10 may havea stent retrieval member 30 securably disposed thereat. A perspectiveview of a stent retrieval member 30 is depicted in FIG. 4. The stentretrieval member 30, which may also be referred to as a stent retrievalloop, is useful for repositioning and/or retrieval of an implanted ordeployed stent 10. The stent retrieval member 30 allows the practitionerto contract and move the stent 10 within the implanted lumen. The stentretrieval member may be made from a memory shape alloy, such as theabove described materials, including nitinol. The use of a shape memorymaterial, as compared other convention materials such as suture thread,has numerous advantages. For example, the self-supporting nature of theshape memory material facilitates the locating of the stent retrievalmember 30, particularly since it does not sag or flop, but remainssubstantially stationary once implanted. A memory shape alloy member 30will not tangle, a potential problem with suture loops, and will alsoaid in opening the stent 10. Another advantage from using a memory shapealloy material is the wire loop defining the member 30 would be lesslikely to break than a plastic or polymeric loop when a pulling force isapplied, such as required for repositioning or removal of the stent 10.

As depicted in FIG. 4 the stent retrieval member 30 includes a generallycircular base 32 and a shaped projection 34. The circular base 32 is agenerally circular perimetric base, i.e., in the form of an elongatewire disposed in a generally circular configuration. The circular base32 may also be described as a generally circular ring. The projection 34includes first and second spaced apart members 36, 38. The spaced apartmembers 36, 38 extend from the circular base 32 at a parted region 33 ofthe circular base 32 and are connected by an apical portion 40 opposedfrom the circular base 32. The parted region 33 may be described as aninterrupted portion of the circular base 32 and is further defined byopposed parted wire ends 35 and 37. The projection 34 extends from thecircular base 32 in a substantially perpendicular fashion. The presentinvention, however, is not limited to a perpendicularly extendingprojection 32, and as described below other extending orientations maysuitably be used.

FIG. 5 depicts a top view of the stent retrieval member 30 of FIG. 4taken along the 5-5 axis. As depicted in FIG. 5, the stent retrievalmember 30 has a circular or a substantially circular base 32. Thepresent invention, however, is not so limited and other shaped bases maysuitably be used. Desirably, the shape of the base 32 matches orsubstantially matches the cross-sectional shape of the stent 10 ateither of its opposed open ends 12, 14.

FIG. 6 is a front elevational view of the stent retrieval member 30 ofFIG. 4 taken along the 6-6 axis. As depicted in FIG. 6, the shapedprojection 32 extends from a substantially planar base 32. FIG. 7 is aright elevational view of the stent retrieval member 30 of FIG. 4 takenalong the 7-7 axis. As depicted in FIG. 7, the shaped projection 34 mayextend in a substantially perpendicular fashion from the base 32.Further, the shaped projection 34 may also be substantially planar froma side view to reduce the overall profile of the member.

The present invention, however, is not limited to the shaped projection34 as depicted in FIGS. 4 and 6, and other suitably shaped projectionsmay suitably be used. For example, as depicted in FIG. 8, the length orspacing between the spaced apart members 36, 38 may be increased to forma wider shaped loop with a less pointed or more rounded apical region40. The shaped projection 34 as depicted in FIG. 8 may also be describedas being “U-shaped”. Such U-shaped projections may include straight orsubstantially straight spaced apart members 36, 38 and a curved apicalregion 40. The present invention, however, is not limited to straight orsubstantially straight members 36, 38 and other shapes, such as curvedor slightly curved, may suitably be used. Such shaped projections 34 maybe described as being or lobed-shaped, generally lobed-shaped orsubstantially lobed-shaped.

Further, as depicted in FIG. 8, the spaced apart members 36, 38 of theshaped projection 34 define an open base, B, of the shaped projection34. The base B is further defined by a length L₁, which is the distancebetween the members 36, 38 thereat. Further, the apical region 40defines a height, H₁, from base B to the apex or summit of the apicalregion 40. Desirably, the height, H₁, is greater than the length, L₁.

As depicted in FIG. 9, a stent retrieval member 42 may include twosubstantially straight spaced apart members 44, 46. The spaced apartmembers 44, 46 may be formed from separate members and joined togetherat the apical region 48 so that the member 48 is in the form of orsubstantially in the form of a triangle with an open base.Alternatively, the spaced apart members 44, 46 may be formed from asingle elongate member and sharply bent at the apical region 48 to formthe open triangular shape. Desirably, the members 44 and 46 are ofsubstantially equal lengths. Such a stent retrieval member 42 may alsobe described as being generally V-shaped. While the apical region 48 isdepicted as having a relatively sharp bend, the present invention is notso limited. For example, the apical region 48 may have a curved portionwith a radius of curvature.

In another embodiment, a shaped projection 50 may be in the form of atrapezoid. As depicted in FIG. 10, members 52 and 54 of shapedprojection 50 as substantially straight segments joined at a planarapical region 56. The lengths of the members 52 and 54 are depicted asbeing substantially equal in FIG. 10. In such a case, the shapedprojection 50 is formed in the shape of an isosceles trapezoid, or ashape substantially representing an isosceles trapezoid, but having anopen base opposed from the apical region 56. While the intersection ofthe members 52 and 54 with the apical region 56 are depicted by sharpbends in FIG. 10, the present invention, however, is not so limited. Thebends may be some what rounded, i.e., having some curvature or radius ofcurvature.

In yet other embodiments as depicted in FIGS. 11 and 12, the shapedprojection may be semi-circular, such as shaped projection 58, orsemi-elliptical, such as shaped projection 60. Further, as depicted inFIG. 13, shaped projection 62 may include straight members 64 and 66that are joined by a rounded or curved apical region 68. Further, asdepicted in FIG. 13, the spaced apart members 64, 66 of the shapedprojection 62 define an open base, B, of the shaped projection 62. Thebase, B, is further defined by a length L₁, which is the distancebetween the members 64, 66 thereat. Further, the apical region 68defines a width, W₁, which is a distance between the spaced apartmembers 64, 66 at the apical region 68. Desirably, as depicted in FIG.13, the length, L₁ is greater than the width, W₁. Such spaced apartmembers 64, 68 may also be described as being obliquely disposed to oneand the other. The present invention, however, is not so limited, andthe width, W₁, at the apical region 68 may be greater than the length,L₁, between the spaced apart members 64, 66 at the base, B. Further,while the members 64, 66 are depicted in FIG. 13 as being straight orsubstantially straight, the present invention is not so limited. Themembers 64, 66 may be curved or slightly curved.

As described above, any of the above-described stent retrieval members,such as but not limited to stent retrieval member 30, may be securablydisposed or securably attached to either or both of the opposed openends 12, 14 of the stent 10. As depicted in FIG. 14 stent retrievalmember 30 is disposed at the open end 14 of the stent 10. As depicted inFIGS. 14 and 15, the shaped projection 34 extends longitudinally beyondthe open end 14 of the stent 10. Such longitudinal projection of thestent retrieval member 30 facilitates grasping of the member 30 by auser for retrieval or repositioning of the stent 10 from a bodily lumen.The closed stent loops 13 at stent end 14 may be equally longitudinallyextending or may be longitudinally offset as depicted in FIGS. 14 and15. The longitudinal offsetting of the stent loops 13 reduces stentdeployment force. Such offsetting is described in additional detail inU.S. Provisional Application No. 60/626,729, filed Nov. 10, 2004 andentitled “Atraumatic Stent With Reduced Deployment Force, Method ForMaking The Same And Method And Apparatus For Deploying And PositioningThe Stent”, the contents of which is incorporated herein by reference.

As depicted in FIG. 16, the stent retrieval member 30 may be securablyattached to the stent end 14 by looping the generally circular base 32through the closed stent loops 13. The elongate wire forming the stentretrieval member 30 may be welded onto itself to form a unitarystructure. The present invention, however, is not limited to the use ofwelding to form a unitary structure, and other joining techniques ormethods may suitably be used. For example, portions of the elongate wireforming the stent retrieval member 30 may be joined together through theuse of a hypotube (not shown). Alternatively, the elongate wire portionsmay be crimped or tied in a knot to form a unitary structure.

As described above, the shaped projection 34 may extend perpendicularlyor substantially perpendicularly from the generally circular base 32 ofthe stent retrieval member 30 and generally longitudinally parallel tothe wall 16 of the stent 10. The present invention, however, is not solimited. For example, as depicted in FIGS. 17 and 18, shaped projection34′ may be inwardly disposed relative to the interior of the stent 10.For example, the shaped projection 34′ of the stent retrieval member 30′may include an inwardly projecting region 70 from which other portions72 and 74 of the stent retrieval member 34′ may be suitably be disposed.The present invention is not limited to the use of the inwardlyprojecting region 70 for an inwardly projecting stent retrieval member30′. For example, as depicted in FIG. 18, stent retrieval member 30″ mayinclude a shaped projection 34″ which is acutely disposed from the base32″ of the stent retrieval member 30″.

The memory shape alloy retrieval member or loop 30 may be used with anymetal or polymeric stents. The main purpose of the retrieval member orloop 30 is to facilitate movement of the stent once the stent has beendeployed. When the projection 34 is pulled along an axis of the stent10, such as the longitudinal axis of the stent 10, the circular base 32contracts in diameter to pull the end 14 of the stent 10 radiallyinward. This action removes the contact force of the end of the stent onthe lumen and reduces the profile of the stent for a safe and easymaneuvering of the stent. Once the pulling force on the retrieval loopis removed, the stent self-expands against the lumen in its newposition. Desirably, the pulling force excludes any twisting force.Further, the retrieval member 30 desirably does not include any barbs,eyelets or the like so that the member 30 has a low profile and does notinterfere with the intended purpose or function of the stent 10.

The stent retrieval member or loop 30 may be made from Nitinol wirewound on a mandrel of the same diameter or larger than the diameter ofthe end of the stent 10. A larger diameter retrieval loop 30 will havemore spring force when placed in or onto a smaller diameter stent. Ahigher spring force may be desirable because it can facilitate inradially expanding the stent 10, as well as preventing the loop 30 fromtangling on the stent. The retrieval member 30 may be shaped with asingle protruding projection 34 or with multiple protruding projections34. A stent retrieval member or loop 30 having more than one protrudingprojection 34 is depicted in FIG. 16A. As described above, the shape ofthe protruding projection 34, which may also be referred to as an accessloop, may vary in size, angle and wire diameter.

As depicted in FIG. 19, the stent 10 may be fully, substantially orpartially covered or lined with a polymeric material 102. The stent 10may also be embedded in a polymeric coating. The covering may be in theform of a tubular structure. Nonlimiting examples of useful polymericmaterials include polyesters, polypropylenes, polyethylenes,polyurethanes, polynaphthalenes, polytetrafluoroethylenes, expandedpolytetrafluoroethylene, silicone, and combinations and copolymersthereof. Desirably, the polymeric material 102 is silicone. Thepolymeric material and/or silicone 102 may be disposed on externalsurfaces 104 of the stent 10, as depicted in FIG. 20, or disposed on theinternal surfaces 106 of the stent 10, as depicted in FIG. 21, orcombinations thereof.

With any embodiment, the stent 10 may be used for a number of purposesincluding to maintain patency of a body lumen, vessel or conduit, suchas in the coronary or peripheral vasculature, esophagus, trachea,bronchi colon, biliary tract, urinary tract, prostate, brain, and thelike. The devices of the present invention may also be used to support aweakened body lumen or to provide a fluid-tight conduit for a bodylumen.

Also, the stent 10 may be treated with any known or useful bioactiveagent or drug including without limitation the following:anti-thrombogenic agents (such as heparin, heparin derivatives,urokinase, and PPack (dextrophenylalanine proline argininechloromethylketone); anti-proliferative agents (such as enoxaprin,angiopeptin, or monoclonal antibodies capable of blocking smooth musclecell proliferation, hirudin, and acetylsalicylic acid);anti-inflammatory agents (such as dexamethasone, prednisolone,corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine);antineoplastic/antiproliferative/anti-miotic agents (such as paclitaxel,5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones,endostatin, angiostatin and thymidine kinase inhibitors); anestheticagents (such as lidocaine, bupivacaine, and ropivacaine);anti-coagulants (such as D-Phe-Pro-Arg chloromethyl keton, an RGDpeptide-containing compound, heparin, antithrombin compounds, plateletreceptor antagonists, anti-thrombin antibodies, anti-platelet receptorantibodies, aspirin, prostaglandin inhibitors, platelet inhibitors andtick antiplatelet peptides); vascular cell growth promotors (such asgrowth factor inhibitors, growth factor receptor antagonists,transcriptional activators, and translational promotors); vascular cellgrowth inhibitors (such as growth factor inhibitors, growth factorreceptor antagonists, transcriptional repressors, translationalrepressors, replication inhibitors, inhibitory antibodies, antibodiesdirected against growth factors, bifunctional molecules consisting of agrowth factor and a cytotoxin, bifunctional molecules consisting of anantibody and a cytotoxin); cholesterol-lowering agents; vasodilatingagents; and agents which interfere with endogenous vascoactivemechanisms.

Further, with any embodiment of the stent 10 the general tubular shapemay be varied. For example, the tubular shape may have a varieddiameter, may be tapered, and may have an outwardly flared end and thelike. Further, the ends of the stent may have a larger diameter than themiddle regions of the stent. In one particularly useful embodiment, atleast one of the ends of the stent transition from one diameter toanother diameter. Desirably, both ends transition in this manner toyield “flared” ends, as depicted in FIG. 19.

The stent may be coated with a polymeric material. For example, thestent wires may be partially or fully covered with a biologically activematerial which is elutably disposed with the polymeric material.Further, the polymeric coating may extend over or through theinterstitial spaces between the stent wires so as to provide a hollowtubular liner or cover over the interior or the exterior surface of thestent. The polymeric material may be selected from the group consistingof polyester, polypropylene, polyethylene, polyurethane,polynaphthalene, polytetrafluoroethylene, expandedpolytetrafluoroethylene, silicone, and combinations thereof.

In one aspect of the present invention, an implantable distensible bandis provided. The band comprises an elongate member comprising agenerally circular perimetric base implantable within a bodily lumen anda shaped projection having first and second spaced apart membersextending acutely or perpendicularly from the base and connected by anapical portion, whereby force exerted on the shaped projection causescontraction or expansion of the circular base. The elongate member maybe a strand, such as a wire strand, either a monofilament ormultifilament strand. Desirably, such bands may function as retrievalmembers when used in conjunction with a stent or a graft.

Desirably, the elongate member comprises a biocompatible materialselected from the group consisting of nitinol, cobalt-based alloy,stainless steel, platinum, gold, titanium, tantalum, niobium, polymericmaterials and combinations thereof. Moreover, the elongate membercomprises a biocompatible, shape-memory material, such as asuper-elastic material. Desirably, The elongate member comprisesnitinol.

The circular base of the implantable distensible band may be parteddefining opposed parted ends, wherein the first spaced apart memberextends from one of the opposed ends and the second spaced apart memberextends from the other the opposed end.

The shaped projection of the implantable distensible band may beU-shaped, V-shaped, shaped as an isosceles trapezoid, shaped as a loop,lobe-shaped, semicircular-shaped, semi-elliptical-shaped, or the like,and combinations thereof.

Desirably, the shaped projection of the implantable distensible band hasan open base defined by a length between the spaced apart members and aheight of the apical region defined by a length from the open base andthe apical region, wherein the height of the apical region is greaterthat the length of the open base. The shaped projection of theimplantable distensible band may also have an open base defined by alength between the spaced apart members and a width of the apical regiondefined by a lateral length between the spaced apart members at theapical region, wherein the length of the open base is greater than thewidth of the apical region.

Desirably, the apical region of the implantable distensible band iscurved.

Desirably, the spaced apart members of the shaped projection of theimplantable distensible band are obliquely disposed to one and theother.

Desirably, the force on the implantable distensible band is a pullingforce for contraction of the band, preferably, a pulling force withoutany twisting force.

In another aspect of the present invention, an implantable stent isprovided. The stent comprises: (i) a distensible tubular stent having atubular structure having a tubular wall defined by an interior surfaceand an exterior surface and having opposed open ends; and (ii) a stentretrieval member comprising an elongate member comprising a generallycircular perimetric base and a shaped projection having first and secondspaced apart members extending acutely or perpendicularly from the baseand connected by an apical portion, whereby force exerted on the shapedprojection causes contraction or expansion of the circular base, whereinthe circular base is securably attached to one of the open ends of thestent and further wherein the shaped projection extends longitudinallybeyond the one open end of the stent. Desirably, the stent comprises oneor more elongate strands braided to form the stent. The plurality ofelongate strands may be braided in a series of closed stent loops at thefirst open end to define an atraumatic stent end, i.e., a stent endhaving no sharp terminating wires. The circular base of the stentretrieval loop may be securably attached to the closed stent loops atthe atraumatic stent end. The circular base may be interlooped with theclosed stent loops. Alternatively, or in addition to, portions of thecircular base may be welded to the closed stent loops, may be clamped tothe closed stent loops, or the like, and combinations thereof.

In this aspect of the present invention, the stent retrieval member maybe similarly shaped and made of similar materials as the above-describedimplantable distensible band. Further, prior to attachment of the stentretrieval member to the stent, the diameter of the circular base of thestent retrieval member may be greater than the diameter of the firstopen end of the stent. The circular base may contract the open end ofthe stent upon application of a pulling force upon the shaped projectionof the stent retrieval member. Desirably, the force is a pulling forcefor contraction of the circular base and the first open end of thestent. The force may be a pulling force without any twisting force. Theshaped projection of the stent retrieval member may be longitudinallyparallel to the wall of the stent or in other words may extend from thestent while being approximately parallel to the stent wall.Alternatively or additionally, the apical region of the shapedprojection of the stent retrieval member may be inwardly disposedrelative to the interior surface of the stent.

In another aspect of the present invention, a method of retrieving orrepositioning an implanted stent is provided. The method comprises thesteps of (a) providing a tubular distensible stent comprising (i) a wallto define an interior surface and an exterior surface and having opposedopen ends; and (ii) a stent retrieval member comprising an elongatemember comprising a generally circular perimetric base implantablewithin a bodily lumen and a shaped projection having first and secondspaced apart members extending acutely or perpendicularly from the baseand connected by an apical portion, whereby force exerted on the shapedprojection causes contraction or expansion of the circular base, whereinthe circular base is securably attached to one of the open ends of thestent and further wherein the shaped projection extends longitudinallybeyond the one open end of the stent; (b) implanting the stent within abodily lumen; and (c) pulling the shaped projection of the stentretrieval member to contract the first end of the stent and to move thestent.

In another aspect of the present invention, a method of retrieving orrepositioning an implanted stent is provided. The method comprises thesteps of (a) locating a distensible stent within a bodily lumen, thestent comprising a hollow tubular structure having a tubular wall todefine an interior surface and an exterior surface and having opposedopen ends and a stent retrieval member comprising an elongate membercomprising a generally circular perimetric base implantable within abodily lumen and a shaped projection having first and second spacedapart members extending acutely or perpendicularly from the base andconnected by an apical portion, whereby force exerted on the shapedprojection causes contraction or expansion of the circular base, whereinthe circular base is securably attached to one of the open ends of thestent and further wherein the shaped projection extends longitudinallybeyond the one open end of the stent; and (b) pulling the shapedprojection of the stent retrieval member to contract the first end ofthe stent and to move the stent. Desirably, the step of pulling theshaped projection excludes twisting of the shaped projection.

In another aspect of the present invention, a system is provided. Thesystem comprises (a) a distensible stent, said stent comprises (i) ahollow tubular structure having a tubular wall to define an interiorsurface and an exterior surface and having opposed open ends; and (ii) astent retrieval member comprising an elongate member comprising agenerally circular perimetric base implantable within a bodily lumen anda shaped projection having first and second spaced apart membersextending acutely or perpendicularly from said base and connected by anapical portion, whereby force exerted on said shaped projection causescontraction or expansion of said circular base, wherein said circularbase is securably attached to one of said open ends of said stent andfurther wherein said shaped projection extends longitudinally beyondsaid one open end of said stent; and (b) a delivery catheter forimplanting said stent. The system may further comprise forceps forengaging the shaped projection of the stent retrieval member.

Various stent types and stent constructions may be employed in theinvention. Among the various stents useful include, without limitation,self-expanding stents and balloon expandable extents. The stents may becapable of radially contracting, as well and in this sense can best bedescribed as radially distensible or deformable. Self-expanding stentsinclude those that have a spring-like action which causes the stent toradially expand, or stents which expand due to the memory properties ofthe stent material for a particular configuration at a certaintemperature. Nitinol is one material which has the ability to performwell while both in spring-like mode, as well as in a memory mode basedon temperature. Other materials are of course contemplated, such asstainless steel, platinum, gold, titanium and other biocompatiblemetals, as well as polymeric stents. The configuration of the stent mayalso be chosen from a host of geometries. For example, wire stents canbe fastened into a continuous helical pattern, with or without awave-like or zig-zag in the wire, to form a radially deformable stent.Individual rings or circular members can be linked together such as bystruts, sutures, welding or interlacing or locking of the rings to forma tubular stent. Tubular stents useful in the present invention alsoinclude those formed by etching or cutting a pattern from a tube. Suchstents are often referred to as slotted stents. Furthermore, stents maybe formed by etching a pattern into a material or mold and depositingstent material in the pattern, such as by chemical vapor deposition orthe like. Examples of various stent configurations are shown in U.S.Pat. No. 4,503,569 to Dotter; U.S. Pat. No. 4,733,665 to Palmaz; U.S.Pat. No. 4,856,561 to Hillstead; U.S. Pat. No. 4,580,568 to Gianturco;U.S. Pat. No. 4,732,152 to Wallsten, U.S. Pat. No. 4,886,062 to Wiktor,and U.S. Pat. No. 5,876,448 to Thompson, all of whose contents areincorporated herein by reference.

The invention being thus described, it will now be evident to thoseskilled in the art that the same may be varied in many ways. Suchvariations are not to be regarded as a departure from the spirit andscope of the invention and all such modifications are intended to beincluded within the scope of the following claims.

What is claimed is:
 1. An implantable stent comprising: a distensibletubular stent having a tubular structure having a tubular wall definedby an interior surface and an exterior surface and having opposed firstand second open ends; and a stent retrieval member comprising aself-supporting elongate member comprising a generally circularperimetric base and two shaped projections, each shaped projectionhaving first and second spaced apart members extending perpendicularlyfrom said base and connected by an apical portion, whereby force exertedon said shaped projections causes contraction or expansion of saidcircular base, wherein said circular base is securably attached to saidtubular wall of said stent, wherein each of said shaped projectionsextends longitudinally away from said tubular wall and past one of saidfirst or second open ends of said stent, wherein said shaped projectionof said stent retrieval member is approximately parallel to the stentwall.
 2. The stent of claim 1, further comprising one or more elongatestrands braided to form said stent.
 3. The stent of claim 2, whereinsaid plurality of elongate strands are braided in a series of closedstent loops having angular bends at said first open end to define anatraumatic stent end.
 4. The stent of claim 3, wherein said circularbase of said stent retrieval member is securably attached to said closedstent loops at said atraumatic stent end.
 5. The stent of claim 4,wherein said circular base is interlooped with said closed stent loops.6. The stent of claim 4, wherein portions of said circular base arewelded to said closed stent loops.
 7. The stent of claim 4, whereinportions of said circular base are clamped to said closed stent loops.8. The stent of claim 1, wherein said elongate member of said stentretrieval member is a strand.
 9. The stent of claim 1, wherein saidelongate member of said stent retrieval member comprises a biocompatiblematerial selected from the group consisting of nitinol, cobalt-basedalloy, stainless steel, platinum, gold, titanium, tantalum, niobium,polymeric materials and combinations thereof.
 10. The stent of claim 1,wherein said elongate member of said stent retrieval member comprises asuper-elastic material.
 11. The stent of claim 1, wherein said elongatemember of said stent retrieval member comprises nitinol.
 12. The stentof claim 1, wherein said circular base is parted defining opposed partedends and further wherein a first spaced apart member of a first of thetwo shaped projections extends from one of said opposed ends and asecond spaced apart member of the first of the two shaped projectionsextends from the other said opposed end.
 13. The stent of claim 12,wherein said shaped projection of said stent retrieval member isU-shaped.
 14. The stent of claim 12, wherein said shaped projection ofsaid stent retrieval member is V -shaped.
 15. The stent of claim 12,wherein said shaped projection of said stent retrieval member is shapedas an isosceles trapezoid.
 16. The stent of claim 12, wherein saidshaped projection of said stent retrieval member is shaped as a loop.17. The stent of claim 12, wherein said shaped projection of said stentretrieval member is lobe-shaped.
 18. The stent of claim 12, wherein saidshaped projection of said stent retrieval member is semicircular-shaped.19. The stent of claim 12, wherein said shaped projection of said stentretrieval member is semi-elliptical-shaped.
 20. The stent of claim 12,wherein each of the two shaped projections of said stent retrievalmember has an open base defined by a length between said spaced apartmembers and a height of said apical region defined by a length from saidopen base to said apical region, wherein said height of said apicalregion is greater that said length of said open base.
 21. The stent ofclaim 12, wherein each of the two shaped projections of said stentretrieval member has an open base defined by a length between saidspaced apart members and a width of said apical region defined by alateral length between said spaced apart members at said apical region,wherein said length of said open base is greater than said width of saidapical region.
 22. The stent of claim 12, wherein, prior to attachmentof said stent retrieval member to said stent, the diameter of saidcircular base of said stent retrieval member is greater than thediameter of said first open end of said stent.
 23. The stent of claim12, wherein said circular base contracts said first open end of saidstent upon application of a pulling force upon said shaped projection ofsaid stent retrieval member.
 24. The stent of claim 1, wherein saidapical region of each of the two shaped projections is curved.
 25. Thestent of claim 1, wherein said spaced apart members of each of the twoshaped projections are obliquely disposed to one and the other.
 26. Thestent of claim 1, wherein said apical region of said shaped projectionof said stent retrieval member has is inwardly disposed relative to saidinterior surface of said stent.
 27. The stent of claim 1, wherein saidforce is a substantially non-twisting pulling force for contraction ofsaid circular base and said first open end of said stent.
 28. The stentof claim 1, wherein said circular base is securably attached to saidtubular wall at one side of said first open end of said stent.
 29. Asystem comprising: (a) a distensible stent, said stent comprising: (i) ahollow tubular structure having a tubular wall to define an interiorsurface and an exterior surface and having opposed first and second openends; and (ii) a stent retrieval member comprising a self-supportingelongate member comprising a generally circular perimetric baseimplantable within a bodily lumen and two shaped projections, eachshaped projection having first and second spaced apart members extendingperpendicularly from said base and connected by an apical portion,whereby force exerted on said shaped projection causes contraction orexpansion of said circular base, wherein said circular base is securablyattached to said tubular wall of said stent, wherein each of said shapedprojections extends longitudinally away from said tubular wall and pastone of said first one or second open ends of said stent, and whereinsaid shaped projection of said stent retrieval member is approximatelyparallel to the stent wall; and (b) a delivery catheter for implantingsaid stent.
 30. The system of claim 29 further comprising: forceps forengaging said shaped projection of said stent retrieval member.
 31. Thesystem of claim 29, wherein said circular base is securably attached tosaid tubular wall at one side of said first open end of said stent. 32.An implantable stent comprising: a distensible tubular stent comprisingone or more elongate strands braided or wound to define a tubularstructure having a tubular wall defined by an interior surface and anexterior surface and having opposed first and second open ends; and astent retrieval member comprising an elongate member comprising agenerally circular perimetric base and two shaped projections, eachshaped projection having first and second spaced apart members extendingperpendicularly from said base and connected by an apical portion,whereby force exerted on said shaped projections causes contraction orexpansion of said circular base, wherein said one or more elongatestrands are angular bent with a bend angle from about 30° to about 150°in a series of closed stent loops at said first open end to define anatraumatic stent end, wherein said circular base is securably attachedto said tubular wall at one or more of the closed stent loops at saidfirst open end of said stent, wherein said shaped projections extendlongitudinally away from said tubular wall and past an opposed side ofsaid first one open end of said stent, and wherein said shapedprojections of said stent retrieval member are approximately parallel tothe stent wall.
 33. The stent of claim 32, wherein said circular base isinterlooped with said one or more closed stent loops.
 34. The stent ofclaim 32, wherein said circular base is parted defining opposed partedends and further wherein said first spaced apart member extends from oneof said opposed ends and said second spaced apart member extends fromthe other said opposed end.
 35. The stent of claim 34, wherein saidshaped projections of said stent retrieval member are selected from thegroup consisting of a V-shaped projection, a V-shaped projection, anisosceles-trapezoid-shaped projection, a loop-shaped projection, alobe-shaped projection, a semicircular-shaped projection or asemi-elliptical-shaped projection.
 36. The stent of claim 32, whereinsaid elongate member of said stent retrieval member comprises asuper-elastic material.
 37. The stent of claim 32, wherein said elongatemember of said stent retrieval member comprises nitinol.
 38. The stentof claim 32, wherein said elongate member of said stent retrieval memberis a metallic strand selected from the group consisting of amonofilament metallic strand or a multifilament metallic strand.
 39. Thestent of claim 32, wherein said elongate member of said stent retrievalmember does not include any barbs or eyelets.
 40. The stent of claim 32,wherein said force is a substantially non-twisting pulling force forcontraction of said circular base and said first open end of said stent.